The Parliament of Ukraine adopted Law No. 4454-IX “On Amendments to Certain Laws of Ukraine Regarding the Implementation of the Bolar Provision”. This law amends the Laws “On Medicines” and “On Protection of Rights to Inventions and Utility Models,” finally harmonizing Ukrainian legislation with EU practices to ensure a “Day-1 Launch” mechanism.
What actions are now permitted for generic pharmaceutical companies during the patent term?
According to the updated Article 31 of the Patent Law, the following actions are not considered patent infringement (including Supplementary Protection Certificates – SPC):
1. Preparation for marketing authorization: Importation, manufacturing, storage, and transportation of the product for the purpose of conducting studies (physicochemical, pre-clinical, clinical) required for the registration dossier.
2. Registration Proceedings (a marketing authorization for a medicine): Submitting an application for marketing authorization, undergoing expert review, adoption of the decision on registration, entering data into the State Register, and obtaining the Marketing Authorization (registration certificate).
3. Manufacturing Waiver (Export): Manufacturing the product during the SPC term specifically for export to third countries. The manufacturer must apply the “UA Export” marking, unless such marking violates the regulations of the destination country.
Mandatory Requirement: 80-Day Notification
The law introduces a strict safeguard to balance interests. Any entity intending to submit data for registration during the patent term is obligated to notify the patent holder in writing.
• Deadline: No later than 80 calendar days before the date of submitting the information/application for registration.
Liability and Risks
The law significantly strengthens liability for patent infringement (e.g., commercial launch before patent expiry):
• Fines: The court may impose a fine ranging from 100% to 500% of the income (revenue) obtained by the violator from the sale of the infringing product.
• Cancellation of Registration: If a court establishes a violation of IP rights during the circulation of the medicine, the state registration of such a product may be cancelled.
Transitional Provisions
It is important to note that the new rules regarding additional protection (including Bolar exemptions and Manufacturing Waivers) apply even to those patents whose validity was extended under the legislation in force prior to the 2020 patent reform.
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